Bone substitute material on the base of natural bones

Abstract

The bone substitute material on the base of natural bone is rendered completely free of albumin and antigen by premaceration, pyrolization and sintering and its frame work consists of only the natural mineral structure of the natural bone. In the process of production of this bone substitute material the bone pieces are submitted to a pretreatment with warm water for removing of the soft parts, subsequently takes place a dealbumination by means of a solution of 10 to 30% H 2 O 2 in a shaking machine and a degreasing with ether. The bone pieces treated in this way are subsequently submitted to a combustion in a stove at 400° C. to 1500° C. and then to a sintering. This bone substitute material which may exist in the shape of the bone part to be replaced forms a form stable matrix for the bone regeneration in which only pure "mineral bone" is present so that no immunogen reactions can take place. The process which includes combustion and sintering is considerably shorter than known processes.

We claim: 
     
       1. A process for producing a shapable bone substitute material capable of bioactivation from a base of natural bone, comprising the steps of: removing any soft parts adhering to the natural bone;   removing albumin from the natural bone by immersion in a solution consisting of one of the group of 10% H 2  O 2  and trysin essentially without the use of caustic material;   degreasing the natural bone by means of ether;   heating the natural bone in accordance with a slowly increasing, controlled temperature profile to a temperature in the range of from about 400° C. to 1500° C. under a supply of air to combust any remaining collagen substances without damaging the mineral structure of the bone;   sintering the natural bone to vitrify its mineral structure and form the bone substitute material; and   slowly cooling the resulting material.   
     
     
       2. The process according to claim 1 wherein the step of slowly cooling comprises cooling for on the order of 24 hours to prevent stresses, cracks or brittleness. 
     
     
       3. The process according to claim 1 wherein the step of heating further comprises: heating the natural bone to a temperature of about 400° C. over a time period of about fifteen minutes and subsequently heating the natural bone to a temperature of about 800° C. over the following about fifteen minute time period and subsequently heating the natural bone to a temperature of between about 800° C. and 1500° C.; and   wherein the step of sintering further comprises sintering the natural bone for a period of at least about two hours.   
     
     
       4. The process according to claim 3 wherein the step of heating further comprises heating the bone to a temperature of about 1200°-1300° C. in about one hour and the step of sintering further comprises sintering for about 4 to 18 hours. 
     
     
       5. The process of claim 1 wherein said step of heating further comprises heating to a temperature in the range of from about 1200°-1300° C. 
     
     
       6. The process according to claim 1 wherein the step of removing soft parts further comprises: heating the natural bone in a water bath at a temperature of 40° C. to 50° C.; mechanically removing the soft parts from the bone;   spraying the bone with a strong water stream; and   spin drying the bone at 50° C.; and   wherein the step of removing albumin further comprises immersing the bone in a solution of 10 to 30% H 2  O 2  in a shaking machine and drying the bone in a warm air stream.   
     
     
       7. The process according to claim 1 further comprising the step of sterilizing the bone substitute material by subjecting said material to radiation. 
     
     
       8. The process according to claim 1 further comprising the step of introducing at least one of the group comprising fibrin, dissolved collagen and antibiotics in powder or dissolved form to the bone substitute material to reinforce bone regeneration effects. 
     
     
       9. The process of claim 1 further comprising the step of shaping the bone substitute material in the form of a bone part to be replaced. 
     
     
       10. The process of claim 1 further comprising step of forming the bone substitute material in the form of chip. 
     
     
       11. The process of claim 1 further comprising step of forming the bone substitute material in the form of slice. 
     
     
       12. The process of claim 1 further comprising step of forming the bone substitute material in the form of cube. 
     
     
       13. The process according to claim 1 further comprising the step of inoculating the bone substitute material with autologous bone marrow extract. 
     
     
       14. The process according to claim 1 further comprising the step of providing the bone substitute material with holes before the heating and sintering steps. 
     
     
       15. The process of claim 14 wherein the step of providing the bone substitute with holes further comprises drilling holes having a diameter on the order of about 3 mm. and a raster distance of about 10 mm. 
     
     
       16. The process of claim 15 further comprising the step of providing the bone substitute material with an artificial article for increased stability during use. 
     
     
       17. The process of claim 15 further comprising the step of providing the bone substitute material with a marrow space rail. 
     
     
       18. The process of claim 17 further comprising the step of providing the bone substitute material with a centro-medullar pegging. 
     
     
       19. The process of claim 17 further comprising the step of providing the bone substitute material with an osteosynthesis plate.